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I heard about AZD-103 two years ago – the media were very excited about it. Both the scientists who developed the drug and the clinical study centre are in Toronto, where we live, so I contacted the researchers to volunteer Mom. They already had their Phase 1 test case volunteers, but advised me to check back for Phase II. I have contacted them every few months. The time may be now. On their website I found:

Press Release: Aug 30, 2007

Transition Therapeutics Announces Completion of Phase I Clinical Studies with Alzheimer’s Disease Drug Candidate ELND-005/AZD-103

TORONTO, Aug. 30th, 2007 – Transition Therapeutics Inc. (“Transition”) (NASDAQ: TTHI, TSX: TTH) announced today the completion of Phase I clinical studies with Alzheimer’s disease drug candidate ELND-005/AZD-103. Transition and its development partner Elan Corporation, plc. (“Elan”) (NYSE: ELN) have performed multiple Phase I studies evaluating the safety, tolerability and pharmacokinetic profile of ELND-005/AZD-103 in healthy volunteers. Orally administered ELND-005/AZD-103 may act through the unique mechanism of preventing and reversing the fibrilization of beta-amyloid in preclinical studies, presumed to be the toxic peptide in the brain of Alzheimer’s patients. ELND-005/AZD-103 is well positioned as a potential Alzheimer’s therapy as it is a small molecule that crosses the blood brain barrier and has exhibited a favourable safety profile.

“We are very pleased with the Phase I data showing that the drug is safe and well tolerated at all doses examined and achieves levels in the CSF and brain that have been shown to be effective in breaking down beta-amyloid fibrils in preclinical studies,” said Dr. Tony Cruz, CEO of Transition. “ELND-005/AZD-103 continues to show very favourable properties for the treatment of Alzheimer’s disease.”

Approximately 110 subjects have been exposed to ELND-005/AZD-103 in multiple Phase I studies, including single and multiple ascending dosing; pharmacokinetic evaluation of levels in the brain; and CSF and plasma studies. ELND-005/AZD-103 was safe and well-tolerated at all doses and dosing regimens examined. There were no severe or serious adverse events observed. ELND-005/AZD-103 was also shown to be orally bioavailable, cross the blood-brain barrier and achieve levels in the human brain and CSF that were shown to be effective in animal models for Alzheimer’s disease. The pharmacokinetic data and safety data obtained in the Phase I studies will be used to select the appropriate doses for the Phase II studies.

The next steps in the development of ELND-005/AZD-103 will be submission of data supporting Phase II studies to the FDA. Transition and Elan anticipate starting Phase II by the end of 2007 or early 2008.

About Transition

Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition’s lead products include ELND-005/AZD-103 for the treatment of Alzheimer’s disease and regenerative therapies E1-I.N.T..™ and GLP1-I.N.T..™ for the treatment of diabetes. Transition has an emerging pipeline of preclinical drug candidates developed using its proprietary drug discovery engine. Transition’s shares are listed on the NASDAQ under the symbol “TTHI” and the Toronto Stock Exchange under the symbol “TTH”.

Notice to Readers: Information contained in our press releases should be considered accurate only as of the date of the release [...]

Source: www.transitiontherapeutics.com/news.

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Categories: Alzheimer's, Medical Technology
Tags » Alzheimer's | medical

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